Muscle Stimulation in Advanced Idiopathic Pulmonary Fibrosis (MUST-IPF)

Royal Brompton & Harefield NHS Foundation Trust

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Other: Home exercise programme; Device: Active NMES; Device: Sham NMES; Other: Breathlessness advice

Study type: Interventional

Funder types: Other

Identifiers

NCT03499275

241055

Details and patient eligibility

About

The aims of this study are to determine whether neuromuscular stimulation (NMES) of the quadriceps muscle is acceptable to patients with Idiopathic Pulmonary Fibrosis (IPF) and staff and whether it can impact clinical and healthcare resource usage outcomes.

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Full description

Patients with IPF who consent to participate in the study will be allocated by chance to use 'active' or 'sham/placebo' NMES for six weeks. Patients will also complete a home exercise programme and receive advice on how to manage breathlessness. Clinical outcomes and trial flow after this six week programme and six weeks after patients have stopped using NMES will be assessed. After this point, healthcare resource use during the study period will be evaluated and interviews involving participants, their carers, and staff about their experiences of the study and using or delivering NMES will be conducted.

Enrollment: 23 patients

Sex: All

Ages: 19 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of IPF according to international standards.
• Severe respiratory disability / breathlessness (Medical Research Council dyspnoea score ≥3).
• Able to provide written informed consent.
• Declined or failed to complete a supervised centre-based pulmonary rehabilitation (PR) programme
• Quadriceps maximum voluntary contraction <80% predicted.

Exclusion criteria

• Cardiac pacemaker.
• Co-existing neurological condition.
• Change in medication or exacerbation requiring admission in preceding four weeks.
• Current regular exerciser (structured supervised training ≥3 times per week within last month).
• People who have completed PR in the previous six months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups

Sham NMES

Sham Comparator group

Description:

Sham neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management

Treatment:

Other: Breathlessness advice

Device: Sham NMES

Other: Home exercise programme

Active NMES

Experimental group

Description:

Neuromuscular electrical stimulation plus home exercise programme and advice on breathlessness management

Treatment:

Other: Breathlessness advice

Device: Active NMES

Other: Home exercise programme